Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200159
Company: SANDOZ INC
Company: SANDOZ INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/03/2012 | ORIG-1 | Approval | Not Applicable |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/200159Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/28/2024 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
06/09/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
CISATRACURIUM BESYLATE
INJECTABLE;INJECTION; EQ 2MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209144 | EUGIA PHARMA |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203183 | FRESENIUS KABI USA |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216538 | HAINAN POLY |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209334 | HENGRUI PHARMA |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203078 | HIKMA |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203079 | HIKMA |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203236 | HOSPIRA |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203238 | HOSPIRA |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211668 | MEITHEAL |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211669 | MEITHEAL |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215516 | PIRAMAL CRITICAL |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201836 | SAGENT PHARMS INC |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201851 | SAGENT PHARMS INC |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200159 | SANDOZ INC |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209132 | SOMERSET |
CISATRACURIUM BESYLATE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212171 | ZYDUS PHARMS |
CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209665 | EUGIA PHARMA |
CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203182 | FRESENIUS KABI USA |
CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216539 | HAINAN POLY |
CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204960 | HENGRUI PHARMA |
CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200154 | SANDOZ INC |
CISATRACURIUM BESYLATE PRESERVATIVE FREE | CISATRACURIUM BESYLATE | EQ 2MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206791 | SOMERSET THERAPS LLC |